AnyPlus® - Cervical Rasp, - GS Medical Co., Ltd.

Duns Number:688385418

Device Description: Cervical Rasp,

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More Product Details

Catalog Number

GS136-3712

Brand Name

AnyPlus®

Version/Model Number

GS136-3712

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

HTR

Product Code Name

Rasp

Device Record Status

Public Device Record Key

49631691-25a4-4544-9e24-c12878ccbe10

Public Version Date

September 30, 2020

Public Version Number

1

DI Record Publish Date

September 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GS MEDICAL CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 7396